Motinorm - instructions for use, dose, side effects, contraindications

Increases the duration of peristaltic contractions of the antral part of the stomach and duodenum, accelerates the emptying of the stomach in case of slowing of this process, increases the tone of the lower esophageal sphincter, eliminates the development of nausea and vomiting.

Stimulates the release of prolactin from the pituitary gland. Antiemetic action may be due to a combination of peripheral (gastrokinetic) action and antagonism to dopamine receptors in the chemoreceptor trigger zone. Domperidone has no effect on gastric secretion.

Domperidone poorly penetrates the blood-brain barrier, so the use of domperidone is rarely accompanied by the development of extrapyramidal side effects.

Pharmacokinetics:

Suction

After oral administration domperidone quickly absorbed. It has low bioavailability (about 15%). Eating and lowering the acidity of the gastric contents reduces the absorption of domperidone. The maximum concentration in the plasma is reached in 30-60 minutes.

Distribution

Domperidone is widely distributed in various tissues, in the brain tissues its concentration is low. Binding to plasma proteins is 91-93%.

Metabolism

It is subjected to intensive metabolism in the wall of the intestine and liver.

Excretion

It is excreted through the intestine (66%) and kidneys (33%), in unchanged form, respectively, 10% and 1% of the dose value. The half-life is 7-9 hours, with prolonged renal failure, it lengthens. In patients with severe renal insufficiency (serum creatinine> 6 mg / 100 ml, ie> 0.6 mmol / L), the half-life of domperidone increased from 7.4 to 20.8 hours, but plasma concentrations were lower than in healthy volunteers.

Indications:

Dyspepsia (a feeling of overflow in the epigastrium, a sensation of bloating, pain in the upper abdomen, belching, flatulence, heartburn).

Nausea and vomiting of a functional, organic, infectious origin, and also caused by radiotherapy, drug therapy (incl.dopamine agonists - levodopa and bromocriptine) or a violation of the diet.

Contraindications:

Hypersensitivity, gastrointestinal bleeding, mechanical obstruction, perforation of the stomach or intestine, prolactinoma, children under 5 years.

Carefully:

Hepatic / kidney failure.

Pregnancy and lactation:

Reception during pregnancy and lactation is possible only if the intended benefit exceeds the possible risk to the fetus or child.

Dosing and Administration:

Inside.

1. Chronic dyspepsia

Adults: 10 mg (1 tablet) 3 times a day, 15-30 minutes before meals and, if necessary, before bed.

Children older than 5 years: 2.5 mg per 10 kg body weight 3 times daily before meals and, if necessary, before bed.

If necessary, the indicated dosage can be doubled.

The course of treatment is 4 weeks.

2. Acute and subacute conditions (primarily nausea and vomiting).

Adults: 20 mg (2 tablets) 3-4 times daily before meals and at bedtime.

Children older than 5 years: 5 mg per 10 kg body weight 3-4 times a day before meals and at bedtime.

Do not administer the drug to children weighing less than 35 kg.

With renal insufficiency it is recommended to reduce the frequency of taking the drug (see section "Special instructions").

Side effects:

From the digestive system: transient intestinal spasms.

From the nervous system: extrapyramidal disorders (in children and people with increased permeability of the blood-brain barrier).

Allergic reactions: skin rash, hives.

Other: hyperprolactinemia (galactorrhea, gynecomastia).

Overdose:

Symptoms: drowsiness, disorientation and extrapyramidal reactions.

Treatment: reception of activated carbon, when extrapyramidal reactions occur - anticholinergic, anti-Parkinsonian, antihistamines.

Interaction:

Cimetidine, sodium hydrogen carbonate, other antacid and antisecretory drugs reduce the bioavailability of domperidone.

Anticholinergic drugs neutralize the action of domperidone.

Increase the concentration of domperidone in plasma: antifungal agents of the azole series, antibiotics from the macrolide group, HIV protease inhibitors, nefazodone.

Compatible with the use of antipsychotic drugs (neuroleptics), dopaminergic receptor agonists (bromocriptine, L-dopa).

Simultaneous reception with paracetamol and digoxin had no effect on the concentration of these drugs in the blood.

Special instructions:

In patients with severe renal insufficiency (serum creatinine> 6 mg / 100 ml, ie> 0.6 mmol / L), the half-life of domperidone increased from 7.4 to 20.8 hours, but plasma concentrations were lower than in healthy volunteers. Since a very small percentage of the drug is excreted by the kidneys unchanged, it is hardly necessary to correct a single dose in patients with renal insufficiency. However, with a repeated appointment, the frequency of administration should be reduced to 1-2 times a day, depending on the severity of the failure. It may also be necessary to reduce the dose. With prolonged therapy, patients should be under regular supervision.

Form release / dosage:Tablets, 10 mg.

Packaging:

10 tablets per blister from Al / Al.

By 2, 3, 5 or 10 blisters together with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C, in a dry place.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after the expiration date indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-001276/09

Date of registration:20.02.2009

Expiration Date:Unlimited

The owner of the registration certificate:Medley Pharmaceuticals, Ltd. Medley Pharmaceuticals, Ltd. India

Manufacturer: & nbsp

MEDLEY PHARMACEUTICALS, Ltd. India

Information update date: & nbsp31.05.2018

Illustrated instructions

Instructions

Motinorm (Motinorm)